Definition
Regulatory requirements that AI-enabled medical devices be watched continuously after launch — because AI behaviour can drift as real-world data changes — rather than cleared once and forgotten. The UK medicines regulator is opening a dedicated sandbox phase to design this post-market oversight. Manufacturers will need to keep monitoring device performance in live clinical use.
Why it matters
AI that performs well in trials can degrade in the field; lifecycle monitoring is becoming the rule in health technology, with direct patient-safety, regulatory, and liability stakes.